Vamed Medical Instrument Co., Ltd.
ChinaFDA 510(k) applicant, unverified FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Vamed Medical Instrument Co., Ltd. makes
Vamed Medical Instrument Co., Ltd. manufactures external counterpulsation systems, including the Soulaire model, designed to improve blood flow and cardiac function through external compression of the legs during specific phases of the heartbeat.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
- GUDID
External Counterpulsation System Ref K190683
510(k) 510(k)External Counterpulsation System, Soulaire Ref K202108
510(k) 510(k)
Company details
- DUNS number
- 545331258
FDA establishments
- Vamed Medical Instrument Co., Ltd Foshan Guangdong · CN FEI 3002806999
Frequently asked questions
How many devices does Vamed Medical Instrument Co., Ltd. have in the registry?
The registry currently lists 3 devices for Vamed Medical Instrument Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vamed Medical Instrument Co., Ltd.'s devices?
Among its 3 most recently registered devices, Vamed Medical Instrument Co., Ltd. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Vamed Medical Instrument Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Vamed Medical Instrument Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vamed Medical Instrument Co., Ltd. in the registry?
The most recently registered devices listed for Vamed Medical Instrument Co., Ltd. include Huawen Soulaire, External Counterpulsation System and External Counterpulsation System, Soulaire.
Which FDA establishments are linked to Vamed Medical Instrument Co., Ltd.?
1 FDA establishment is linked to Vamed Medical Instrument Co., Ltd. in the registry; they are listed on the company page.